Cleared Traditional

K020712 - ELECTRO-NERVE STIMULATOR TENS MODEL BMLS02-4

K020712 is an FDA 510(k) clearance for ELECTRO-NERVE STIMULATOR TENS MODEL BML..., manufactured by Biomedical Life Systems, Inc.. The device is a Class 2 Neurology device with product code GZJ cleared through the Traditional 510(k) pathway after a 203-day FDA review.

K020712 · Biomedical Life Systems, Inc. · Neurology device
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Sep 2002
Decision
203d
Days
Class 2
Risk

K020712 is an FDA 510(k) clearance for the ELECTRO-NERVE STIMULATOR TENS MODEL BMLS02-4. Classified as Stimulator, Nerve, Transcutaneous, For Pain Relief (product code GZJ), Class II - Special Controls.

Submitted by Biomedical Life Systems, Inc. (Vista, US). The FDA issued a Cleared decision on September 24, 2002 after a review of 203 days - an extended review cycle.

This device falls under the Neurology FDA review panel, regulated under 21 CFR 882.5890 - the FDA neurology device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Neurology review framework, consistent with the majority of Class II 510(k) submissions.

View all Biomedical Life Systems, Inc. devices

FDA 510(k) Submission Details - K020712

510(k) Number K020712 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 05, 2002
Decision Date September 24, 2002
Days to Decision 203 days
Submission Type Traditional
Review Panel Neurology (NE)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
54d slower than avg
Panel avg: 149d · This submission: 203d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

GZJ Device Classification - Class 2, Special Controls

Product Code GZJ Stimulator, Nerve, Transcutaneous, For Pain Relief
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 882.5890
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Neurology devices follow this clearance model.

Regulatory Peers - GZJ Stimulator, Nerve, Transcutaneous, For Pain Relief

All 379
Devices cleared under the same product code (GZJ) and FDA review panel - the closest regulatory comparables to K020712.
ELECTRO-NERVE STIMULATOR TENS MODEL BMLS02-10
K022925 · Biomedical Life Systems, Inc. · Nov 2002
V TENS PLUS
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DIGITAL TRANSCUTANEOUS ELECTRICAL NERVE STIMULATOR, MODEL EV-803 DIGITAL TENS
K020749 · Everyway Medical Instruments Co.,Ltd · Oct 2002
FIRST CHOICE & FIRST CHOICE PLUS
K022076 · Body Clock Health Care, Ltd. · Sep 2002
ULTRASTIM KIT
K013532 · Axelgaard Mfg. Co., Ltd. · Aug 2002
MODIFICATION TO PROMAX-XP, TENS AND MICROCURRENT DEVICE
K022405 · Rehabilicare, Inc. · Aug 2002